Maglek B6 Forte

Package Leaflet: Information for the Patient

Maglek B6 Forte, 100 mg of magnesium ions Mg + 10 mg, coated tablets

Magnesium citrate + Pyridoxine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor, pharmacist, or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Maglek B6 Forte and what is it used for
• 2. Important information before taking Maglek B6 Forte
• 3. How to take Maglek B6 Forte
• 4. Possible side effects
• 5. How to store Maglek B6 Forte
• 6. Contents of the pack and other information

1. What is Maglek B6 Forte and what is it used for

Maglek B6 Forte contains magnesium ions and pyridoxine hydrochloride (vitamin B6).
The medicine supplements magnesium deficiencies in the body.
Magnesium is an essential cation for the proper course of many biochemical processes in the body. Its biological role involves the activation of a series of enzymes.
Magnesium plays a significant role in the process of cardiac muscle contraction, affecting the state of neuro-muscular excitability.
Magnesium is only partially absorbed from the gastrointestinal tract, mainly in the small intestine, and the degree of absorption depends on its content in food. Magnesium deficiency can cause disorders in the muscular and central nervous systems. Vitamin B6 increases magnesium absorption from the gastrointestinal tract by 20-40%.
Maglek B6 Forte is recommended for the treatment and prevention of magnesium deficiency.
The occurrence of the following symptoms may indicate a magnesium deficiency:

• nervousness, irritability, mood swings, mild anxiety, restlessness, transient feeling of fatigue, lethargy, sleep disorders of mild severity;
• anxiety symptoms, such as intestinal cramps or heart palpitations (without heart disorders);
• muscle cramps, tingling, eyelid twitching.

Supplementing magnesium can alleviate the above symptoms.
The product should be used after excluding other causes of symptoms than magnesium deficiency and when achieving improvement or increasing magnesium supply is not possible through a proper diet.
In the absence of improvement after a month of taking Maglek B6 Forte, continuing treatment is not recommended.

2. Important information before taking Maglek B6 Forte

When not to take Maglek B6 Forte:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6);
• if the patient has acute renal failure (creatinine clearance <30 ml minute);< li>
• if the patient is taking levodopa;
• if the patient has hypermagnesemia;
• if the patient has significantly low blood pressure;
• if the patient has an atrioventricular block;
• if the patient has a disease called Myasthenia gravis(an acquired, chronic disease characterized by rapid fatigue and weakness of skeletal muscles).

Warnings and precautions

Before starting treatment with Maglek B6 Forte, the patient should discuss it with their doctor, pharmacist, or nurse.
In the case of combined magnesium and calcium deficiency, magnesium deficiency should be corrected first.
In the case of severe magnesium deficiency and malabsorption, treatment should be started under medical supervision with intravenous magnesium administration.
Long-term use of high doses of magnesium may contribute to the development of tooth decay.
Taking the medicine in a dose higher than recommended may cause diarrhea.
Particular caution should be exercised in patients with moderate renal impairment due to the risk of hypermagnesemia.
Long-term use of magnesium may increase blood potassium levels, especially in patients with controlled potassium intake and impaired renal function.
Long-term use of pyridoxine (for several months or years) may cause sensory nerve disorders. Symptoms include: numbness and disturbances of position sense, tingling in hands and feet, as well as progressively worsening coordination disorders. In most cases, symptoms disappear after discontinuation of pyridoxine.
Children and adolescents
Maglek B6 Forte is used in adults and children aged 6 years or older.
In case of any doubts, the patient should consult their doctor or pharmacist.

Maglek B6 Forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor or pharmacist if they are taking any of the following medicines, as they may cause magnesium and/or vitamin B6 deficiency by increasing their excretion from the body or impairing absorption:

• amphotericin B (a medicine used to treat severe systemic fungal infections),
• isoniazid, cycloserine (medicines used to treat tuberculosis),
• bisphosphonates (medicines used to treat osteoporosis),
• diuretics (e.g., thiazides or furosemide),
• cisplatin, cetuximab, or erlotinib (medicines used to treat cancer),
• cyclosporine A, rapamycin (medicines used in transplantation),
• penicillamine (a medicine used to treat rheumatoid arthritis and heavy metal poisoning),
• proton pump inhibitors (medicines used to treat heartburn, such as pantoprazole or omeprazole),
• foscarnet (an antiviral medicine),
• pentamidine (a medicine used to treat parasitic infections or lung infections),
• hydralazine (a medicine used to lower blood pressure),
• phosphates, iron, zinc, or calcium salts,
• oral contraceptives,
• laxatives,
• aminoglycoside antibiotics,
• DNA virus polymerase inhibitors.

In the case of taking these medicines, it may be necessary to individually adjust the dose of Maglek B6 Forte.
The patient should inform their doctor or pharmacist if they are taking levodopa (a medicine used to treat Parkinson's disease), as vitamin B6 may inhibit its action. The patient should also inform their doctor or pharmacist if they are taking phenobarbital and phenytoin (antiepileptic medicines), as vitamin B6 may decrease the blood levels of these medicines.
It is not recommended to take vitamin B6 with cisplatin and altretamine (medicines used to treat cancer). Therapy with these medicines may be less effective.
The patient should not take magnesium-containing medicines and certain antibiotics (fluoroquinolones, tetracyclines) or medicines used to treat osteoporosis (bisphosphonates) at the same time, as magnesium may decrease their absorption from the gastrointestinal tract. The patient should maintain an interval of at least 2-3 hours between taking these medicines and taking Maglek B6 Forte.
When taking magnesium preparations with lithium carbonate, potassium-sparing diuretics (such as amiloride and spironolactone), or other magnesium-containing medicines (such as laxatives or antacids), there is a risk of hypermagnesemia and magnesium toxicity symptoms. The risk is particularly increased in patients with renal impairment.
Magnesium-containing medicines should be taken 3-4 hours before or after administration of medicines such as: aminoquinolines, quinidine and its derivatives, nitrofurantoin, penicillamine, eltrombopag, nitroxoline, in order to avoid absorption disorders.
Magnesium deficiency may increase the risk of digoxin toxicity. However, taking magnesium and digoxin at the same time may disrupt the absorption of the medicine. The patient should maintain a time interval of approximately 2 hours between taking magnesium and digoxin.

Maglek B6 Forte with food, drink, and alcohol

The medicine should be taken during meals, with a glass of water.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only after consulting a doctor.
Studies have not shown any harmful effects of magnesium during pregnancy.
Breastfeeding
The medicine may be used during breastfeeding only in agreement with a doctor.
It is recommended that breastfeeding women take vitamin B6 in a dose not exceeding 20 mg per day.
Fertility
Studies on vitamin B6 have shown its effect on male fertility. However, this effect is only observed at very high doses. Maglek B6 Forte contains small doses of vitamin B6.

Driving and using machines

Maglek B6 Forte does not affect the ability to drive and use machines.

Maglek B6 Forte contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Maglek B6 Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. In case of doubts, the patient should consult their doctor, pharmacist, or nurse.
Adults:
3-4 tablets per day, in 2 or 3 divided doses, during meals.

Use in children and adolescents

from 6 years of age or older (with a body weight of approximately 20 kg):
10-30 mg/kg body weight per day, i.e., 2-4 tablets per day, in 2 or 3 divided doses, during meals.
If the patient feels that the effect of Maglek B6 Forte is too strong or too weak, they should consult their doctor.

Taking a higher dose of Maglek B6 Forte than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
Overdose of magnesium taken orally does not cause toxic reactions in patients with normal renal function.
In patients with renal impairment, magnesium toxicity may occur.

Missing a dose of Maglek B6 Forte

The patient should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Maglek B6 Forte can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with Maglek B6 Forte:
Rare(may affect up to 1 in 1,000 people):

• abdominal pain
• loose stools or diarrhea at the beginning of treatment (usually mild and transient)
• redness of the skin

Very rare(may affect up to 1 in 10,000 people):

• allergic reactions

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Maglek B6 Forte

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 30°C. The blisters should be stored in the outer packaging to protect them from light and moisture.
The medicine should not be used after the expiry date stated on the carton and blister after: EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Maglek B6 Forte contains

• The active substances of the medicine are magnesium citrate and pyridoxine hydrochloride (vitamin B6).

One coated tablet contains 100 mg of magnesium ions in the form of magnesium citrate (Magnesii citras) and 10 mg of pyridoxine hydrochloride (Pyridoxini hydrochloridum).

• Other ingredients are: Tablet core: lactose monohydrate, macrogol 6000, microcrystalline cellulose, crospovidone (Type A), colloidal silica, magnesium stearate. Tablet coating: polyvinyl alcohol, calcium carbonate (E 170), macrogol 4000, talc.

What Maglek B6 Forte looks like and contents of the pack

Biconvex, oval, white or almost white coated tablets with a possible presence of darker spots and an embossed inscription "Mg FORTE" on one side, with a length of 17.2 ± 1 mm and a width of 10.2 ± 0.6 mm.
The pack contains 30, 60, 90, or 120 coated tablets of Maglek B6 Forte, packaged in PVC/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
ul. Ostrzykowizna 14A
05-170 Zakroczym
Phone: +48 22 785 27 60

Date of last revision of the leaflet: